WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

Class I - Dangerous

🏥 Medical Devices Recalled: November 22, 2021 Cardiovascular Systems Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
Lot Numbers: Lot 67876, UDI 011085000049188217221221100000067876 Lot 70309, UDI 011085000049188217230110100000070309 Lot 68706, UDI 011085000049188217221227100000068706 Lot 69543, UDI 011085000049188217230103100000069543 Lot 75758, UDI 011085000049188217230203100000075758 Lot 77278, UDI 011085000049188217230210100000077278 Lot 79994, UDI 011085000049188217230223100000079994 Lot 81252, UDI 011085000049188217230301100000081252 Lot 81986, UDI 011085000049188217230307100000081986 Lot 83080, UDI 011085000049188217230313100000083080 Lot 81998, UDI 011085000049188217230320100000081998 Lot 84796, UDI 011085000049188217230327100000084796 Lot 87909, UDI 011085000049188217230411100000087909 Lot 89035, UDI 011085000049188217230418100000089035 Lot 86622, UDI 011085000049188217230404100000086622 Lot 90096, UDI 011085000049188217230424100000090096 Lot 93949, UDI 011085000049188217230515100000093949 Lot 91603, UDI 011085000049188217230501100000091603 Lot 94895, UDI 011085000049188217230521100000094895 Lot 91939, UDI 011085000049188217230507100000091939 Lot 101930, UDI 011085000049188217230717100000101930
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Cardiovascular Systems Inc
Reason for Recall:: Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

Product Codes/Lot Numbers:

Lot Numbers: Lot 67876, UDI 011085000049188217221221100000067876 Lot 70309, UDI 011085000049188217230110100000070309 Lot 68706, UDI 011085000049188217221227100000068706 Lot 69543, UDI 011085000049188217230103100000069543 Lot 75758, UDI 011085000049188217230203100000075758 Lot 77278, UDI 011085000049188217230210100000077278 Lot 79994, UDI 011085000049188217230223100000079994 Lot 81252, UDI 011085000049188217230301100000081252 Lot 81986, UDI 011085000049188217230307100000081986 Lot 83080, UDI 011085000049188217230313100000083080 Lot 81998, UDI 011085000049188217230320100000081998 Lot 84796, UDI 011085000049188217230327100000084796 Lot 87909, UDI 011085000049188217230411100000087909 Lot 89035, UDI 011085000049188217230418100000089035 Lot 86622, UDI 011085000049188217230404100000086622 Lot 90096, UDI 011085000049188217230424100000090096 Lot 93949, UDI 011085000049188217230515100000093949 Lot 91603, UDI 011085000049188217230501100000091603 Lot 94895, UDI 011085000049188217230521100000094895 Lot 91939, UDI 011085000049188217230507100000091939 Lot 101930, UDI 011085000049188217230717100000101930